Healthcare & Pharma Careers

Several major Biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join the Oncology program.. Candidates should have an M.D. with board certification/eligibility in hematology/oncology, or a PhD, PharmD with at least 5 years of drug development experience.. Provide initial clinical designs for future trials, partnering with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings.. As Medical Monitor, be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines.. Perform regular clinical reviews of listings and partner with clinical operations/drug safety to develop a safety monitoring plan.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.. Developing and communicating CMC regulatory strategies for combination products/medical devices that are in alignment with project goals and timelines.. Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with applicable regulations and guidance governing the development, licensure and marketing of drugs, biologics and /or gene therapy medicinal products.. Minimum requirement is for a bachelor's degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.. RESPONSIBILITIES As an Associate Director in Regulatory Affairs, CMC, focusing on Combination Products and Medical Devices, you will be responsible for: Developing and communicating CMC regulatory strategies for combination products/medical devices that are in alignment with project goals and timelines.. Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with applicable regulations and guidance governing the development, licensure and marketing of drugs, biologics and/or gene therapy medicinal products.. EDUCATION AND EXPERIENCE Minimum requirement is for a bachelor’s degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.

Senior Manager, Medical WritingWho we are: is a biopharmaceutical company that is fueled by connections.. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.. What you bring: 5+ years as a medical or scientific writer, or equivalent professional or educational experience (eg, graduate degree in life sciences).. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

The Regulatory Affairs and Quality Assurance Associate shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, and support in all chosen distribution markets.. Support preparing IDE, 510(k), PMA, CE Mark, and other related regulatory filings.. Establish and implement necessary policies, procedures, templates related to Regulatory Affairs and Quality Assurance. Excellent public speaking, professional writing, typing, and general office application skills are essential for substantial cross-organizational interaction and facilitation, as well as process and record generation.. Experience with Post-Market Surveillance and Clinical Evaluation preferred.

Responsibilities The Research Nurse I will be responsible for rendering patient care services to patients on research protocols approved through the Northside Hospital IRB. Responsibilities involve patient registration, data collection, data submission, adverse event reporting, patient follow-up, records management, protocol regulatory management, quality assurance and other activities related to research.. Major roles of the Research Nurse include those of practitioner, researcher, educator and consultant.. The Research Nurse is a professional person with knowledge, skills and abilities in the following areas: specific disease management nursing, data management, physical assessment skills, leadership ability and communication skills.. Northside Hospital Cancer Institute's (NHCI) Cancer Research Program is one of the largest community-based oncology/hematology programs in the nation and is one of the few cancer research programs in the country offering Phase I-IV clinical trials.. One (1) to three (3) years relevant work experience in a clinical or healthcare settingCertified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA).

Additional Duties for Clinical Research RN Level II (Sr. Professional). Additional Duties for Clinical Research RN Level III (Principal Professional). Clinical Research Nurse - RN I Level (Intermediate Professional). One of the following certifications: OCN - Oncology Certified Nurse (obtained through ONS), CCRP - Certified Clinical Research Professional (obtained through SoCRA), or CCRC - Certified Clinical Research Coordinator (obtained through ACRP). CCRC - Certified Clinical Research Coordinator (obtained through ACRP)

The Clinical Research Coordinator will be responsible for coordinating clinical trials while ensuring protocol adherence and patient safety.. Protects patients and employees by adhering to infection-control policies and protocols, safe medication administration, mixing, and storage procedures, and controlled substance regulations.. Clinical Research Coordinator certification. 289 SW Stonegate Terrace Suite 103. Work environment: While performing the duties of this job, the employee is exposed to environmental risk of radiation exposure, and biohazard exposure.

We are currently seeking a Clinical Research Coordinator to work onsite with the National Institutes of Health in Bethesda, MD.. Opportunity to work at NIH, the world's foremost medical research center. The primary role for this Research Coordinator (RC) position is to provide clinical research coordination and protocol navigation for the NINDS Intramural Research Program.. Preferred Software: Clinical Trial Management System (CTMS), Electronic Medical Records System, Electronic Data Capture System. Certifications and Licenses: Association of Clinical Research Professionals Certified Professional (ACRP-CP), Association of Clinical Research Professionals (ACRP) , Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA)

The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more.. The technician-clinical research is responsible for processing of blood, tissue, urine, and stool specimens for drug development companies conducting clinical trials as well as administrative tasks required to support these functions.. Accordingly, laboratory documentation must conform to GLP and GCP regulations as well as compliance with all relevant study documents.. Patient sample accessioning and handling, centrifugation, aliquoting, freezing, temperature-controlled shipments to central laboratories, temperature-controlled sample processing, and several cell biological techniques, including aseptic technique, working in laminar flow hoods, ficoll density gradients, PBMC dilutions, and automated cell counting.. Develop relationships with pathology, histology, radiology, operating room and surgical departments.

As a Moffitt Clinical Research Coordinator, you’ll bring hope to patients by delivering tomorrow’s cancer treatments today!. Our Clinical Research Coordinators come from a variety of backgrounds and experiences, including social sciences (public health, social work, sociology, psychology, communications, and more), biological sciences, business, and humanities.. The Clinical Research Coordinator role is a terrific opportunity for those who have already worked in other areas of healthcare as well as those who are looking for a new and exciting way to contribute through their career.. Moffitt offers paid training and orientation through its CTO (Clinical Trails Office) Academy.. Clinical Trials These positions work closely with patients, patient families, study sponsors (from smaller pioneer biotech companies through large pharmaceutical companies), and the Clinical Trial Team that includes physicians, pharmacists, nurses, data monitors and data managers.

JOB DESCRIPTION DETAILS Reports to: Director Oncology Services Job Summary: Provides management and oversight of oncology clinical trials conducted at CalvertHealth.. Performs a variety of complex duties to support the conduct of clinical research, such as, facilitating the informed consent process, coordinating required research activities; collecting, compiling, and documenting clinical research data to ensure adherence to protocols and validation of information and documents.. Coordinates pre-award and post-award activities to include assisting to create study budgets/Memorandum of Understanding, preparing Medicare Coverage Analysis and internal cost summaries, reconciling project budgets, facilitating sponsor invoicing, and coordinating site payments.. Education: The position requires an ADN or Diploma of Nursing, BSN or MSN, preferred, or Bachelor's degree in related areas and 2 years of experience in oncology research/clinical.. Must have a current cancer specific certification through an accredited certification program or ongoing education by earning 12 Cancer related continuing education nursing contact hours each year for a total of 36 CEU's per accreditation cycle (3 years).

Your responsibilities include: Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.). to obtain various worldwide approvals to commercially distribute products In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries.. RA certification (by Regulatory Affairs Professional Society) The anticipated annualized base pay range this full-time position working at this location will be from [$69,000 to $112,750], plus variable compensation, i.e., annual bonus target (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at Boston Scientific (BSC), which can be reviewed at.. At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range.. BSC considers various factors in determining actual compensation for this position at the expected location.

About you: Required Qualifications A minimum of 4 years’ experience as a registered nurse (RN), licensed mental health counselor (LMHC), licensed clinical social worker (LCSW), care manager, or healthcare compliance analyst, in a role working with critical care providers, public health providers, or providers that care for children, older adults, persons with traumatic brain injury, persons with emotional disturbances, or persons with developmental disabilities.. One year of experience with monitoring compliance or fee-for-service (FFS) Medicaid or managed care billing.. Experience working with eMedNY, Child Adolescent Needs and Strengths (CANS-NY), Uniform Assessment System for New York (UAS-NY), Medicaid Health Homes, Medicaid Managed Care Organizations (MMCOs), and/ or other related systems/programs/organizations.. Knowledge of New York State Medicaid billing practices/systems.. Experience working with Office of Mental Health (OMH), Office for People with Developmental Disabilities (OPWDD), and/ or Office of Children and Families (OCFS).

Director, Healthcare Analytics (Wisconsin Market Finance) - REMOTE at Molina Healthcare in Meridian, Idaho, United States Job Description Job Description Job Summary Support the Market CFO in Wisconsin FP&A. Performs research and analysis of complex healthcare claims data, and utilization management data for month-end reporting, ad-hoc requests, rate advocacy, and other financial needs.. Evaluates data, writes code, creates dashboard tools, and presents healthcare utilization and cost containment reports across Medicaid, LTSS, Medicare, and Marketplace, and makes recommendations based on relevant findings.. - Reviews high priority analyses, reports, SQL programming, Power BI Reporting, and other Finance projects for accuracy, completeness, return on investment, and compliance with regulatory requirements.. - Strong knowledge of SQL, Databricks, and Power BI or similar visualization tool.. Molina Healthcare offers a competitive benefits and co To view full details and how to apply, please login or create a Job Seeker account

Hybrid Employee Value Proposition: At Taiho Oncology, we recognize the critical role that Clinical Pharmacology and Pharmacometrics (CPP) plays in the development of oncology compounds.. Our Performance Objectives outline a comprehensive approach to developing the overall CPP strategy and reporting plans for all TOI-sponsored clinical trials, ensuring the success of our drug development endeavors.. Position will support the execution of Clinical Pharmacology and Pharmacometrics (CPP) activities related to oncology compound development for Taiho Oncology, Inc.. Degree in Drug Metabolism and Pharmacokinetics related discipline.. A working knowledge of the ICH/FDA/EU guidelines for DMPK.

Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI, industry, cooperative groups or HHC system alliances.. Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring.. Required to attend the respective system-wide Disease Management Team meetings and present the clinical trials to potential investigators.. Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting and continuing reviews.. Assist research account specialist of CCRO with clinical trial billing in the resolution of related queries.

Melissa Owens| President P: (386)339-0839 |E: melissa@alliedsearchpartners.com Schedule a Meeting: Job Description Job Title: Senior Quality Assurance - Permanent Location: Alameda, CAShift: Flexible work schedule, start time between 7am and 9am local time / Hybrid - at least 4 days per week.. Job Summary: A passionate Senior Quality Assurance Specialist to play a vital role in ensuring the quality and compliance of our products business.. The person in this position will collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to review documentation, conduct/host audits, investigate deviations, lead projects, and help manage document lifecycles.. Additionally, the Senior Quality Assurance Specialist will perform back-up quality control duties.. Requirements: Knowledge of quality tools/concepts and their application such as Document Control/Change Control, Deviations, Corrective/Preventive Action, Internal Audit, batch record review, statistical process control, etc.

Do you want to join an organization that invests in you as a(an) Pharmacy Operations Manager?. We are looking for a dedicated Pharmacy Operations Manager like you to be a part of our team.. The Pharmacy Operations Manager provides managerial support to the Director of Pharmacy and other Pharmacy Department Leadership through day to day departmental leadership and coordination of pharmacy workflow.. HCA Healthcare Co-Founder. Our Talent Acquisition team is reviewing applications for our Pharmacy Operations Manager opening.

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond.. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education.. The Stravitz-Sanyal Liver Institute at VCU is seeking an Associate Director of Clinical Trials.. Serves as a resource and leader for participants, CRC’s, and PI’s, research staff in collaboration with the health system’s ambulatory clinic manager and staff.. Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.